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FDA Approval Activities for this Drug…

Cefazolin for Injection USP, 500mg and 1g, Hikma Farmaceutica (Portugal), Lda ANDA 65-047 9/18/01 4/10/03 Cefazolin for Injection USP, 500mg and 1g, American Pharmaceutical Partners ANDA 64-169 8/14/98 8/20/98 Cefazolin for Injection USP, 10g/vial and 20g/vial Fujisawa USA, ANDA 64-170 3/18/98 2/22/99 Cefazolin for Injection USP & Dextrose Injection USP B. Braun Medical NDA 50-779 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL CEFAZOLIN SODIUM AM PARTNERS 064169 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM AM PARTNERS 064170 CEFAZOLIN SODIUM Injection 20GM BASE/VIAL CEFAZOLIN SODIUM AM PARTNERS 064169 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM AM PARTNERS 062831 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL CEFAZOLIN SODIUM APOTHECON 062831 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM APOTHECON 062831 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM APOTHECON 050779 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN AND DEXTROSE B BRAUN 050779 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN AND DEXTROSE B BRAUN 063002 CEFAZOLIN SODIUM Injection 10MG BASE/ML ANCEF IN PLASTIC CONTAINER Baxter 063002 CEFAZOLIN SODIUM Injection 20MG BASE/ML ANCEF IN PLASTIC CONTAINER Baxter 050461 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL ANCEF GLAXOSMITHKLINE 064033 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM GLAXOSMITHKLINE 050461 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL ANCEF GLAXOSMITHKLINE 050461 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL ANCEF GLAXOSMITHKLINE 050461 CEFAZOLIN SODIUM Injection 5GM BASE/VIAL ANCEF GLAXOSMITHKLINE 063209 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL CEFAZOLIN SODIUM HANFORD GC 063207 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM HANFORD GC 063208 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM HANFORD GC 063214 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM HANFORD GC 063216 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM HANFORD GC 061773 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL KEFZOL LILLY 061773 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL KEFZOL LILLY 061773 CEFAZOLIN SODIUM Injection 20GM BASE/VIAL KEFZOL LILLY 061773 CEFAZOLIN SODIUM Injection 250MG BASE/VIAL KEFZOL LILLY 061773 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL KEFZOL LILLY 062989 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL CEFAZOLIN SODIUM MARSAM 062988 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM MARSAM 062989 CEFAZOLIN SODIUM Injection 20GM BASE/VIAL CEFAZOLIN SODIUM MARSAM 062988 CEFAZOLIN SODIUM Injection 250MG BASE/VIAL CEFAZOLIN SODIUM MARSAM 062988 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM MARSAM 062989 CEFAZOLIN SODIUM Injection 5GM BASE/VIAL CEFAZOLIN SODIUM MARSAM 063018 CEFAZOLIN SODIUM Injection 10GM BASE/VIAL CEFAZOLIN SODIUM Teva 063018 CEFAZOLIN SODIUM Injection 5GM BASE/VIAL CEFAZOLIN SODIUM Teva 065047 CEFAZOLIN SODIUM Injection 1GM BASE/VIAL CEFAZOLIN SODIUM WESTWARD 065047 CEFAZOLIN SODIUM Injection 500MG BASE/VIAL CEFAZOLIN SODIUM WESTWARD Ancef (cefazolin) Injection, GlaxoSmithKline Ancef (cefazolin) Injection, GlaxoSmithKline Cefazolin for Injection USP and Dextrose Injection USP, B. Braun Medical Inc., Labeling Revision | Cefazolin Injection, Hikma Farmaceutica, Approval | ANCEF (cefazolin for injection) Intravenous, GlaxoSmithKline, Labeling Revision | Cefazolin Injection, Orchid Healthcare, Approval | Cefazolin Injection, Orchid Healthcare, Approval | Cefazolin for Injection USP and Dextrose Injection, B. Braun Medical, Labeling Revision | Cefazolin for Injection USP and Dextrose Injection, B. Braun Medical, Labeling Revision

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